HE4 will be available through Roche’s automated immunoassay analyzers.
Fujirebio Diagnostics and Roche Diagnostics entered a worldwide license and supply agreement for the HE4 ovarian cancer test. Roche will develop an assay kit utilizing Fujirebio Diagnostics’ HE4 test on its automated immunoassay analyzers.
The HE4 test was developed by Fujirebio Diagnostics to be used in conjunction with the company’s existing CA125 biomarker to more accurately distinguish between benign and malignant pelvic masses. HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with epithelial ovarian cancer (EOC). It also has the CE marked of approval in Europe to help estimate the risk of EOC in premenopausal or postmenopausal women presenting with pelvic mass.
The HE4 manual test and corresponding Risk of Ovarian Malignancy algorithm are pending an FDA okay for use in women who present with a pelvic mass.